Geographic Atrophy of the MaculaPhase 2SIGLECNCT05839041
A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
A Phase 2 study testing AVD-104 and Avacincaptad in people with Geographic Atrophy of the Macula and Macular Degeneration, run by Aviceda Therapeutics, Inc. at 56 sites in United States.
Trial summary
Investigate the Safety, Pharmacokinetics, and Treatment effects of Single and Multi-dose of Intravitreal AVD-104 in participants with geographic atrophy secondary to age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Geographic Atrophy of the Macula, Macular Degeneration
- What is being tested?
- AVD-104 and Avacincaptad
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 56 sitesUnited States
- Study dates
- 2 May 2023to 18 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1:
- BCVA in the study eye using ETDRS Chart Visual Acuity Scale (VAS) of 5 to 55 letters (equivalent to Snellen VA of approximately 20/800 - 20/80)
- If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA)
- GA may be center involved.
- Part 2:
- BCVA in the study eye using ETDRS Chart VAS of 24 letters or better (equivalent to Snellen VA of 20/320 or better)
- Confirmed diagnosis of AMD that is non-center involving (i.e., non-sub-foveal) GA in 50% of participants. Center involvement allowed in 50% of participants.
- The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Part 1 and 2
- Presence of the following ocular conditions - in the Study Eye:
- Exudative AMD or choroidal neovascularization (CNV), including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography (SD-OCT) imaging and/or fluorescein angiography as assessed by the Reading Center.
- Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
Retina Research Institute of Texas Abilene TX
Abilene, Texas, 79606
Texas Retina Associates
Arlington, Texas, 76012
Southeast Retina Center
Augusta, Georgia, 30909
Austin Retina Associates
Austin, Texas, 78705
Retina Associates of Cleveland, Inc
Beachwood, Ohio, 44122
Mid-Atlantic Retina
Bethlehem, Pennsylvania, 18017
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Retina Center of New Jersey
Bloomfield, New Jersey, 07003
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Retina Consultants of Charleston
Charleston, South Carolina, 29414
University Retina and Macula Associates
Chicago, Illinois, 60439
Retina Associates of Cleveland
Cleveland, Ohio, 44130
Retina Foundation of the Southwest
Dallas, Texas, 75231
Texas Retina Associates
Dallas, Texas, 75231
Rand Eye Institute
Deerfield Beach, Florida, 33064
NJ Retina
Edison, New Jersey, 08820
Retina Vitreous Center
Edmond, Oklahoma, 73013
Erie Retina Research, LLC
Erie, Pennsylvania, 16507
Retina Group of Florida
Fort Lauderdale, Florida, 33308
Texas Retina Associates
Fort Worth, Texas, 76104
Associated Retina Consultants
Gilbert, Arizona, 85297
Macula & Retina Institute
Glendale, California, 91203
Retina Specialists of Michigan
Grand Rapids, Michigan, 49546
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Midwest Eye Institute
Indianapolis, Indiana, 46290
Mississippi Retina Associates
Jackson, Mississippi, 39202
Valley Retina Institute
McAllen, Texas, 78504
Retina Consultants of Minnesota
Minneapolis, Minnesota, 55435
Northern California Retina Vitreous Associates
Mountain View, California, 94040
Tennessee Retina
Nashville, Tennessee, 37203
Illinois Retina Associates
Oak Park, Illinois, 60304
Florida Retina Institute
Orlando, Florida, 32806
Retina Specialty Institute
Pensacola, Florida, 32503
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85021
Sierra Eye Associates
Reno, Nevada, 89502
Kaiser Permanente
Riverside, California, 92505
Associated Retinal Consultants
Royal Oak, Michigan, 48073
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95825
Retinal Consultants Medical Group
Sacramento, California, 95841
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107
Retina Consultants of Texas
San Antonio, Texas, 78240
Retina Consultants of Texas
San Antonio, Texas, 78503
West Coast Retina
San Francisco, California, 94101
RCA: California Retina Consultants
Santa Barbara, California, 93103
Associated Retina Consultants
Scottsdale, Arizona, 85260
Spokane Eye Clinic
Spokane, Washington, 99204
New England Retina Consultants
Springfield, Massachusetts, 01107
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
Retina-Vitreous Surgeons of Central NY
Syracuse, New York, 13088
Southern Vitreoretinal Associates
Tallahassee, Florida, 32308
Retina Consultants of Texas
The Woodlands, Texas, 77384
North Carolina Retina Associates
Wake Forest, North Carolina, 27587
Retina Group of New England, PC
Waterford, Connecticut, 06385
Palmetto Retina Center
West Columbia, South Carolina, 29169
Long Island Vitreoretinal Consultants
Westbury, New York, 11590
Center for Retina & Macular Disease
Winter Haven, Florida, 33880
About this study
Official title: A Single and Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Treatment Effect of Intravitreal AVD-104 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Investigate the Safety, Pharmacokinetics, and Treatment effects of Single and Multi-dose of Intravitreal AVD-104 in participants with geographic atrophy secondary to age-related macular degeneration.
Read the detailed description
Part 1 of the trial will be a multi-center, open label safety and dose escalation study with a potential enrollment of 30 participants having geographic atrophy (GA) secondary to macular degeneration. They will receive a single intravitreal injection of study drug (AVD-104) and will be followed for 3 months for safety observation. They will have both aqueous humor and peripheral blood drawn for pharmacokinetic and pharmacodynamic evaluations.
Part 2 will be a multi-center, double masked, randomized trial to evaluate the treatment effect of AVD-104 on participants with geographic atrophy secondary to macular degeneration. Participants will be randomized to high dose AVD-104, low dose AVD-104, or active comparator (avacincaptad). The primary endpoint will be the difference in the rate of growth of the GA area as measured by fundus autofluorescence.
- Being tested
- AVD-104, Avacincaptad
- Keywords
- Age-related Macular Degeneration, Geographic Atrophy, Dry AMD
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVD-104Drug
Intravitreal injection
AvacincaptadDrug
Intravitreal injection of 2 mg avacincaptad
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Participants will receive a single intravitreal injection of AVD-104 at one of 4 escalating doses. All participants will be followed up for safety until Month 3. Receives: Drug: AVD-104 |
| Part 2: High dose AVD-104 | Active comparator | 100 participants will be randomized and treated with bimonthly intravitreal injections of high-dose AVD-104 for the first 12 months. They will continue bimonthly injections for months 13-24. Receives: Drug: AVD-104 |
| Part 2: Low dose AVD-104 | Active comparator | 100 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months. Receives: Drug: AVD-104 |
| Part 2: Avacincaptad | Active comparator | 100 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal) Receives: Drug: Avacincaptad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose Limiting Toxicity in Part 1
The number of participants experiencing a dose limiting toxicity corresponding to a category of 3 or greater on the National Cancer Institute Common Terminology Criteria for Adverse Events
Measured: 3 months
The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2
The rate of change from baseline in area of GA as measured by fundus autofluorescence at month 12.
Measured: 12 months
Secondary outcomes (1)
Prevention of Vision Loss from Baseline in Participants in Part 2
Proportion of participants with 15 or greater letter loss in best corrected visual acuity (BCVA) (assessed with the Early Treatment Diabetic Retinopathy Study [ETDRS] visual acuity).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start2 May 2023
- Primary completion18 Feb 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic Atrophy of the MaculaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 - Open Label, Multi-Center, Dose Escalation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aviceda Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Callanan, MD, Study director, Aviceda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839041
- Sponsor's protocol ID
- AVD-104-C01
- Acronym
- SIGLEC
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single and Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Treatment Effect of Intravitreal AVD-104 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05839041
- Acronym / sponsor ID
- SIGLEC / AVD-104-C01
- Keywords
- Age-related Macular Degeneration, Geographic Atrophy, Dry AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Aviceda Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the Safety, Pharmacokinetics, and Treatment effects of Single and Multi-dose of Intravitreal AVD-104 in participants with geographic atrophy secondary to age-related macular degeneration.
Detailed description
Part 1 of the trial will be a multi-center, open label safety and dose escalation study with a potential enrollment of 30 participants having geographic atrophy (GA) secondary to macular degeneration. They will receive a single intravitreal injection of study drug (AVD-104) and will be followed for 3 months for safety observation. They will have both aqueous humor and peripheral blood drawn for pharmacokinetic and pharmacodynamic evaluations.
Part 2 will be a multi-center, double masked, randomized trial to evaluate the treatment effect of AVD-104 on participants with geographic atrophy secondary to macular degeneration. Participants will be randomized to high dose AVD-104, low dose AVD-104, or active comparator (avacincaptad). The primary endpoint will be the difference in the rate of growth of the GA area as measured by fundus autofluorescence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Part 1 - Open Label, Multi-Center, Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: AVD-104Participants will receive a single intravitreal injection of AVD-104 at one of 4 escalating doses. All participants will be followed up for safety until Month 3. |
| Part 2: High dose AVD-104 | Active comparator | Drug: AVD-104100 participants will be randomized and treated with bimonthly intravitreal injections of high-dose AVD-104 for the first 12 months. They will continue bimonthly injections for months 13-24. |
| Part 2: Low dose AVD-104 | Active comparator | Drug: AVD-104100 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months. |
| Part 2: Avacincaptad | Active comparator | Drug: Avacincaptad100 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal) |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- BCVA in the study eye using ETDRS Chart Visual Acuity Scale (VAS) of 5 to 55 letters (equivalent to Snellen VA of approximately 20/800 - 20/80)
- If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA)
- GA may be center involved.
- BCVA in the study eye using ETDRS Chart VAS of 24 letters or better (equivalent to Snellen VA of 20/320 or better)
- Confirmed diagnosis of AMD that is non-center involving (i.e., non-sub-foveal) GA in 50% of participants. Center involvement allowed in 50% of participants.
Key exclusion criteria (5 listed)
- Part 1 and 2
- Presence of the following ocular conditions - in the Study Eye:
- Exudative AMD or choroidal neovascularization (CNV), including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography (SD-OCT) imaging and/or fluorescein angiography as assessed by the Reading Center.
- Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVD-104Intravitreal injection | Drug | Part 1, Part 2: High dose AVD-104, Part 2: Low dose AVD-104 |
| AvacincaptadIntravitreal injection of 2 mg avacincaptad | Drug | Part 2: Avacincaptad |
Primary outcome
Occurrence of Dose Limiting Toxicity in Part 1
Time frame: 3 months
The number of participants experiencing a dose limiting toxicity corresponding to a category of 3 or greater on the National Cancer Institute Common Terminology Criteria for Adverse Events
The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2
Time frame: 12 months
The rate of change from baseline in area of GA as measured by fundus autofluorescence at month 12.
1 secondary outcome
Prevention of Vision Loss from Baseline in Participants in Part 2
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Callanan, MD study director
Aviceda Therapeutics
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVD-104 and Avacincaptad in people with Geographic Atrophy of the Macula and Macular Degeneration, run by Aviceda Therapeutics, Inc. at 56 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose Limiting Toxicity in Part 1 (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.